BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1016459 · Received March 19, 2008

    Report

    Report Number
    1119421-2008-00156
    Event Type
    Other
    Date Received
    March 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED ON 02/19/2008, 02/21/2008, 02/28/2008 AND 03/14/2008. ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 03/19/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED SHE IS UNHAPPY WITH HER VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE REPORTS SHE WEARS GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS EVENT (ONE REPORT FOR EACH EYE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN60D3 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other